2020-26156. Agency Information Collection Activities: Submission for OMB Review; Comment Request

AGENCY:

Centers for Medicare & Medicaid Services, Health and Human Services (HHS)

ACTION:

Notice.

SUMMARY:

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

DATES:

Comments on the collection(s) of information must be received by the OMB desk officer by December 28, 2020.

ADDRESSES:

Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain . Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

1. Access CMS' website address at website address at https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.html

2. Call the Reports Clearance Office at [phone].

FOR FURTHER INFORMATION CONTACT:

William Parham at [phone].

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: Extension of a previously approved collection: Title of Information Collection: Transcatheter Valve Therapy (TVT) Registry; Use: The data collection is required by the Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) entitled, “Transcatheter Aortic Valve Replacement (TAVR)”. The TAVR device is only covered when specific conditions are met including that the heart team and hospital are submitting data in a prospective, national, audited registry. The data includes patient, practitioner and facility level variables that predict outcomes such as all cause mortality and quality of life. CMS finds that the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry, one registry overseen by the National Cardiovascular Data Registry, meets the requirements specified in the NCD on TAVR. The TVT Registry will support a national surveillance system to monitor the safety and efficacy of the TAVR technologies for the treatment of aortic stenosis.

The data will also include the variables on the eight item Kansas City Cardiomyopathy Questionnaire (KCCQ-10) to assess heath status, functioning and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptoms (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

The conduct of the STS/ACC TVT Registry and the KCCQ-10 is in accordance with Section 1142 of the Social Security Act (the Act) that describes the authority of the Agency for Healthcare Research and Quality (AHRQ). Under section 1142, research may be conducted and supported on the outcomes, effectiveness, and appropriateness of health care services and procedures to identify the manner in which disease, disorders, and other health conditions can be prevented, diagnosed, treated, and managed clinically. Section 1862(a)(1)(E) of the Act allows Medicare to cover under coverage with evidence development (CED) certain items or services for which the evidence is not adequate to support coverage under section 1862(a)(1)(A) and where additional data gathered in the context of a clinical setting would further clarify the impact of these items and services on the health of beneficiaries.

The data collected and analyzed in the TVT Registry will be used by CMS to determine if the TAVR is reasonable and necessary (e.g., improves health outcomes) for Medicare beneficiaries under Section 1862(a)(1)(A) of the Act. Furthermore, data from the Registry will assist the medical device industry and the Food and Drug Administration (FDA) in surveillance of the quality, safety and efficacy of new medical devices to treat aortic stenosis. For purposes of the TAVR NCD, The TVT Registry has contracted with the Data Analytic Centers to conduct the analyses. In addition, data will be made available for research purposes under the terms of a data use agreement that only provides de-identified datasets. Form Number: CMS-10443 (OMB control number: 0938-1202); Frequency: Annual; Affected Public: Individuals, Households and Private Sector; Number of Respondents: 37,221; Total Annual Responses: 148,884; Total Annual Hours: 47,765. (For policy questions regarding this collection contact Sarah Fulton at 410-786-2749.)

2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Information Collection for Machine Readable Data for Provider Network and Prescription Formulary Content for FFM QHPs; Use: Under 45 CFR 156.122(d)(1)(2), 156.230(b), and 156.230(c), and in the final rule, Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2018 (CMS-9934-F), standards for qualified health plan (QHP) issuers (including Small Business Health Options Program (SHOP) issuers and stand-alone dental plans (SADP) issuers) are established for the submission of provider and formulary data in a machine- readable format to the Department of Health and Human Services (HHS) and for posting on issuer websites. These standards provide greater transparency for consumers, including by allowing software developers to access formulary and provider data to create innovative and informative tools. The Centers for Medicare and Medicaid Services (CMS) is continuing an information collection request (ICR) in connection with these standards. Form Number: CMS-10558 (OMB control number 0938-1284); Frequency: Annually; Affected Public: Private Sector, State, Business, and Not-for Profits; Number of Respondents: 376; Number of Responses: 376; Total Annual Hours: 10,495. (For questions regarding this collection, contact Joshua Van Drei at 410-786-1659).

3. Type of Information Collection Request: Reinstatement with change of a previously approved collection; Title of Information Collection: Home Office Cost Statement; Use: The primary function of the home office cost statement is to provide the documentary support required for a Medicare provider to claim reimbursement for HO/CO costs in their Medicare cost report. A HO/CO must submit an acceptable home office cost statement directly to the servicing contractors for its providers that received a home office cost allocation for reimbursement determinations. Section 1874A of the Act describes the functions of the contractor.

The home office cost statement schedules collect the cost data required to support home office costs claimed in a provider's Medicare cost report. The Schedule S includes the certification statement where the HO/CO attests to the accuracy of the information and allows the HO/CO the opportunity to electronically sign and electronically submit the home office cost statement. The Schedule S-1 collects identifying data about the home office and key officers/employees of the home office. The Schedule S-2 collects identifying information for healthcare provider components, non-healthcare components, and region/division components of the HO/CO, and provides the structure for reporting costs for those components throughout the cost statement. The A series of schedules collects the HO/CO trial balance of expenses, reclassifications, and adjustments, for allocation of the HO/CO costs to its components. On the B series of schedules, the home office directly allocates costs directly attributable to specific components. On the C and D series of schedules, the HO/CO functionally allocates costs to components in a manner that reasonably relates to the services provided to the components. On the E series of schedules, the HO/CO allocates pooled costs (costs not directly assigned or functionally allocated) to the components. On the F series of schedule, the HO/CO summarizes the cost allocations by component. On the G series of schedules, the HO/CO reports financial data from their balance sheet and income statement. Form Number: CMS-287-21 (OMB control number 0938-0202); Frequency: Annually; Affected Public: Private Sector, State, Business, and Not-for Profits; Number of Respondents: 1,626; Number of Responses: 1,626; Total Annual Hours: 757,716. (For questions regarding this collection, contact Gail Duncan at 410-786-7278.)

Dated: November 20, 2020.

William N. Parham, III,

Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.